SOURCES SOUGHT
66 -- Smoking Machine
- Notice Date
- 4/27/2016
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1164039
- Archive Date
- 5/24/2016
- Point of Contact
- Heather Kinsey, Phone: 2404027591
- E-Mail Address
-
heather.kinsey@fda.hhs.gov
(heather.kinsey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: Document Type: Sources Sought - FDA-SS-1164039 Release Date: April 27, 2016 Response Date: May 9 at 12:00pm EST via email to Heather.Kinsey@fda.hhs.gov Contracting Office Address: Food and Drug Administration, 5630 Fisher Lane, Rockville, Maryland 20857; Attn: Heather Kinsey, Contract Specialist Description of Services/Supplies: Smoking Machine, Plus 2 one year options CONTRACTING OFFICE U.S. Department of Health and Human Services (DHHS) Food and Drug Administration Agency (FDA) / Office of Acquisitions and Grants Services (OAGS) DESCRIPTION This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) for the purchase of a Smoking Machine. The Contractor's capability statement shall demonstrate the company's ability to meet the following requirement. Please provide a detailed description of your company's (including its teammates, if applicable) experience and demonstrated abilities to deliver the following: SOW (Statement of Work) The Contractor shall provide the following: 1. One Port Linear Smoking Instrument for Electronic Cigarettes • 1 x 200ml Syringes • Fixed Puff Smoking • Graphical User Interface • Automated Port Leak Checking • GMP/GLP (21 CFR Part II) Compliant 2. Software • Data Stored in Relational Database with Full Audit Capability • Puff Volume - 5 -200cc • Puff Duration - 1 - 4 sec • Puff Interval - 10 - 9999 sec • Multiple puff profiles available 3. Additional Parts included • 1 x Cambridge filter pad holder assemblies • Labyrinth seals and neoprene washers • 1 x How to Instructions - electronically Minimal characteristics that need to be met for the instrument we are seeking are: 1) Maximum puff volume should be 200 mL 2) Multiple puff profiles should be available 3) The smoking machine should be easily able to accommodate addition of four to five ports at a later time. • It is possible that the project may be extended to include more electronic cigarette ports so multiple electronic cigarettes can generate smoke at the same time. To have this future capability we recommend a smoking machine that can provide this flexibility. 4) Should possess a dedicated human-machine interface (HMI) for inputting puff profile 5) The HMI should be able to control up to four or five electronic cigarette ports at the same time. 6) Servicing time should be about 2 weeks 7) Integration to aerosol analyzers for aerosol size and concentration measurements Criteria for coupling system with existing analyzers The company has to provide technical support for easy integration with existing aerosol instruments. 4. Warranty/Maintenance Agreement: Entire system must be warranted for parts and labor for 12 months from date of acceptance. Warranty service should be equivalent to the maintenance agreement requested in the next section. 5. Option Year Maintenance Agreement: As part of this purchase, CDRH seeks an option year maintenance agreement for two option years, beginning on the date of installation and acceptance. This shall not obligate CDRH to purchase the extended warranty. The specific requirements for this optional extended warranty are: a. Service contract coverage must include trouble-shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer. b. Service must be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers should have access to the manufacturer's latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. c. The contract must enable the Project Officer or their designee to have access to the manufacturer's call center at regular business hours (8 am to 5 pm EST) for technical assistance, which is staffed by engineers who provide a high level of expertise for troubleshooting the instrument. d. The supplier must be able to guarantee that a service engineer will be able to work on site within four business days of receiving a call from CDRH. e. One (1) preventative maintenance inspection shall be performed during the 12 month period with all travel, labor, and parts included. This inspection shall include routine preventative maintenance of the instrument, calibration, electrical safety testing and any other preventative maintenance measures deemed necessary by the vendor. f. All software updates to the scientific instrument and/or system software and related installation of such instrument updates and/or system software during the Agreement Term g. Respond to requests for emergency on-site service and/or non-emergency requests (Monday-Friday, excluding vendor and Federal holidays) within 3 business days(72 hours). h. Upon the on-site visit, the contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement. If the repairs are not covered under the service maintenance agreement, the contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs. Turnaround time for an emergency or non-emergency on-site visit to completion of repairs shall not exceed 5 business days (120 hours).  For repairs up to $2,500, not covered by the Maintenance/Support Agreement, the Government shall pay the vendor (with proper Government approvals) with a Government Purchase Card  For repairs over $2,500, not covered by the Maintenance/Support Agreement, the Government will issue a Purchase Order for the repairs  Repair work that is not covered by the Maintenance/Support Agreement is not to be initiated by the vendor unless the Government has given the vendor proper authorization i. One year warranty on all parts and labor h. Service Records and Reports: The vendor shall, commensurate with the completion of each service call, provide the end user of the equipment with a copy of the field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, on-site hours expended and parts/components replaced. In addition, the vendor shall provide monthly reports to the FDA COR and Contract Specialist, not later than the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required. 6. Training: The proposal must include a half day (four hour), on-site familiarization training for multiple users (the FDA estimates 2 users will attend this training session). This training session will take place at the CDRH location. This training session will be arranged by CDRH's project officer. Training session shall take place within 30 days after installation and acceptance by the FDA. This training session should include the following training objectives: a. Provide guidance to CDRH operators on the proper use of the instrument b. Any routine maintenance required by the users c. Any safety and related safeguards as deemed appropriate d. Information on what the users should do if the unit is not functioning properly e. Other topics deemed necessary by the vendor 7. Prices must include all applicable fees including shipping and handling. Responses to this notice shall be limited to 5 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 339112 (size standard of 500 employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System for Award Management (SAM) to be considered as potential sources. 5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. 7. Evidence of experience in work similar in type and scope to include contract numbers, project titles, dollar amounts, points of contact and telephone numbers 8. Past performance references with points of contact and telephone numbers. At least three references are requested. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received via email to Contract Specialist Heather Kinsey at Heather Kisney@fda.hhs.gov no later than 12:00 PM Eastern time on Monday, May 9, 2016 for consideration. Responses to this announcement will not be returned, nor any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and the FDA may contact one or more respondents for clarifications and to enhance the Governments understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1164039/listing.html)
- Place of Performance
- Address: Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04097834-W 20160429/160427235033-29a9297e7fd3444e811ddc18c6442d60 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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